ssd-_alpha_10_manual__number_1_mn1-5205_rev_18_sept.pdf
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MN1-5205 Rev.18
ULTRASOUND DIAGNOSTIC
INSTRUMENT
SSD-α10
Manual Number : MN1-5205
Rev.18
0123
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MN1-5205 Rev.18
VS-FlexGrid Pro
Copyright(C)1999 Videosoft Corporation
Portions of this software are based in part on the work of the Independent JPEG Group.
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MN1-5205 Rev.18
Safety alert symbols
Safety alert symbols
The four indications [Danger], [Warning], [Caution] and [Note] used on this instrument and in this instruction manual have the following meaning.
Danger
Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.
A warning message is inserted here.
Warning
Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
A warning message is inserted here.
Caution
Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury.
A caution message is inserted here.
Note
Indicates a strong request concerning an item that must be observed in order to prevent damage or deterioration of the instrument and also to ensure that it is used efficiently.
An explanatory text is inserted here.
Classification of SSD-α10
• Protection against electric shock: Class I medical electrical equipment
• Applied parts:Type BF applied parts
• Protection against defibrillator emissions: Not compatible with defibrillator-proof applied parts
• Protection against harmful ingress of water or particulate matter: Ordinary protection (IPX0)
• Level of safety for use in air and flammable anesthetic gas, or in oxygen/nitrous oxide and flammable anesthetic
gas:
This instrument is not suitable for use in air and flammable anesthetic gas, or in oxygen/nitrous oxide and flammable anesthetic gas.
• Operation mode: Continuous operation
1
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MN1-5205 Rev.18
CONTENTS
This book consists of two separate volumes.
These two volumes have the same table of contents and the index respectively.
1. Precautions for Use
1-1.
1-2.
Purpose of Use ............................................................................................................................................. 1-1
1-1-1.
Precautions concerning acoustic power ....................................................................................... 1-2
1-1-2.
Use with an ultrasound contrast agent ......................................................................................... 1-2
1-1-3.
Use with a general pharmaceutical .............................................................................................. 1-2
1-1-4.
Use with Other Medical Devices ................................................................................................. 1-3
Classification................................................................................................................................................ 1-4
1-2-1.
According to the type of protection against electric shock:......................................................... 1-4
1-2-2.
According to the degree of protection against electric shock: ..................................................... 1-4
1-2-3.
According to the degree of protection against harmful ingress of water ..................................... 1-4
1-2-4.
According to the degree of safety of application in the presence of a flammable anaesthetic mixture
with air or with oxygen or nitrous oxide1-4
1-2-5.
According to the mode of operation............................................................................................. 1-4
1-3.
Safety ........................................................................................................................................................... 1-5
1-4.
Environmental Conditions ........................................................................................................................... 1-6
1-4-1.
Working environment .................................................................................................................. 1-6
1-4-2.
Storage environment and moving / transport environment.......................................................... 1-6
1-5.
Power Requirements .................................................................................................................................... 1-7
1-6.
Electromagnetic compatibility ..................................................................................................................... 1-8
1-7.
1-6-1.
The prevention of electromagnetic wave disorders ..................................................................... 1-8
1-6-2.
The guideline of electromagnetic compatibility .......................................................................... 1-9
1-6-3.
Guidance and declaration directive concerning electromagnetic emission ................................. 1-9
1-6-4.
Restrictions for use..................................................................................................................... 1-10
1-6-5.
Essential performance ................................................................................................................ 1-10
1-6-6.
Guidance and Declaration directive concerning electromagnetic immunity ............................ 1-12
1-6-7.
Guidance and Declaration directive concerning electromagnetic immunity
(conduction RF and emission RF).............................................................................................. 1-13
Safety Instructions for Connecting Network Devices................................................................................ 1-15
1-7-1.
1-8.
Electrical safety Instructions for Connecting Network Devices ................................................ 1-15
Other precautions ....................................................................................................................................... 1-15
2. Meaning of Symbols, Indications and Terms
2-1.
Symbols and Indications .............................................................................................................................. 2-1
2-1-1.
Safety alert symbols ..................................................................................................................... 2-1
2-1-2.
Other symbols and indications ..................................................................................................... 2-2
2-2.
Meaning of Terms........................................................................................................................................ 2-4
2-3.
Position of Labels......................................................................................................................................... 2-5
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MN1-5205 Rev.18
3. Installation Method
3-1.
3-2.
Environmental Conditions of Installation Location ..................................................................................... 3-1
3-1-1.
Working environment................................................................................................................... 3-1
3-1-2.
ESD prevention procedures .......................................................................................................... 3-2
3-1-3.
Installation location ...................................................................................................................... 3-3
3-1-4.
Power source................................................................................................................................. 3-3
Installing the Instrument............................................................................................................................... 3-4
3-2-1.
3-3.
Connecting a Probe to the Instrument .......................................................................................................... 3-5
3-3-1.
3-4.
Method of connecting an electronic type probe ........................................................................... 3-5
Connecting Options to the Instrument.......................................................................................................... 3-7
3-4-1.
3-5.
Installation procedure ................................................................................................................... 3-4
Connecting the instrument to the physiological signal terminal .................................................. 3-7
Connecting with Other instrument ............................................................................................................... 3-9
4. Specifications and Name of Each Part
4-1.
Specifications................................................................................................................................................ 4-1
4-2.
Name and Function of Each Part.................................................................................................................. 4-5
4-2-1.
Exterior drawing and name of each part....................................................................................... 4-5
4-2-2.
Front panel .................................................................................................................................... 4-7
4-2-3.
Rear panel ..................................................................................................................................... 4-9
4-2-4.
Caster .......................................................................................................................................... 4-10
4-2-5.
Viewing monitor......................................................................................................................... 4-11
4-2-6.
Physiological signal Connector .................................................................................................. 4-12
5. COMPOSITION
5-1.
Standard composition ................................................................................................................................... 5-1
5-2.
Options.......................................................................................................................................................... 5-2
5-2-1.
Peripheral instrument.................................................................................................................... 5-2
5-2-2.
Table of optional probes (EU nations).......................................................................................... 5-5
5-2-3.
Table of optional probes (Outside EU)......................................................................................... 5-9
6. Principle of Operation
6-1.
Principle of Operation .................................................................................................................................. 6-1
7. Cleaning and Sterilizing
7-1.
7-2.
Method of Cleaning and Sterilizing the Instrument ..................................................................................... 7-1
7-1-1.
Cleaning that is carried out at the end of each day ....................................................................... 7-1
7-1-2.
Cleaning that must be carried out once a week ............................................................................ 7-1
7-1-3.
Cleaning that must be carried out once a month........................................................................... 7-2
7-1-4.
Cleaning that is carried out as necessary after use ....................................................................... 7-2
Cleaning and Sterilizing Conditions............................................................................................................. 7-4
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MN1-5205 Rev.18
8. Preparations for Use
8-1.
8-2.
Starting Inspection ....................................................................................................................................... 8-1
8-1-1.
External Inspection....................................................................................................................... 8-1
8-1-2.
Checking and Replacing Consumables........................................................................................ 8-1
8-1-3.
Cleaning, disinfecting and Sterilizing Probes .............................................................................. 8-1
8-1-4.
Operation check ........................................................................................................................... 8-2
Preparations for Use..................................................................................................................................... 8-2
8-2-1.
Adjusting the monitor .................................................................................................................. 8-2
8-2-2.
Adjusting the height of the operation panel ................................................................................. 8-5
8-2-3.
Adjusting the position of the operation panel .............................................................................. 8-6
8-2-4.
Adjusting the Angle and Position of the Monitor ........................................................................ 8-7
9. Screen Display
9-1.
Character Display......................................................................................................................................... 9-1
9-1-1.
9-2.
Automatic display area................................................................................................................. 9-2
Graphic Display ........................................................................................................................................... 9-4
10. After Using the Instrument
10-1.
Switching OFF the Instrument................................................................................................................... 10-1
10-1-1.
10-2.
10-3.
Procedure for switching OFF the instrument ............................................................................. 10-1
Cleaning the Instrument ............................................................................................................................. 10-1
10-2-1.
Cleaning that is carried out at the end of each day .................................................................... 10-1
10-2-2.
Cleaning that must be carried out once a week.......................................................................... 10-2
10-2-3.
Cleaning that is carried out as necessary after use..................................................................... 10-2
State of the Instrument and Accessories .................................................................................................... 10-2
11. Storing the Instrument
11-1.
Preparations for Storing the Instrument ..................................................................................................... 11-1
11-1-1.
11-2.
Storage preparation procedure ................................................................................................... 11-1
Storage Location and Environmental Conditions ...................................................................................... 11-2
11-2-1.
Storage environment .................................................................................................................. 11-2
12. Moving the Instrument
12-1.
12-2.
Instrument
12-3.
Precaution for moving................................................................................................................................ 12-1
State of the Instrument and Accessories Before Moving the
12-1
12-2-1.
Moving preparation.................................................................................................................... 12-1
12-2-2.
Moving procedure ...................................................................................................................... 12-3
Inspection Before Re-use ........................................................................................................................... 12-3
13. Safety Inspection
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MN1-5205 Rev.18
13-1.
13-2.
Maintenance and Inspection ....................................................................................................................... 13-1
13-1-1.
Weekly inspection ...................................................................................................................... 13-1
13-1-2.
Monthly inspection ..................................................................................................................... 13-1
13-1-3.
Issues that require caution about electrostatic discharge (ESD)................................................. 13-2
Safety Inspection ........................................................................................................................................ 13-3
13-2-1.
13-3.
Periodic Safety Inspection Procedure, and Measurement .......................................................... 13-3
Checking the Measurement Accuracy........................................................................................................ 13-6
13-3-1.
Inspection method....................................................................................................................... 13-6
13-3-2.
Evaluation of results ................................................................................................................... 13-7
13-3-3.
Inspection Procedure .................................................................................................................. 13-8
13-4.
Measurement Accuracy Inspection Data Sheet ........................................................................................ 13-11
13-5.
ULTRASOUND DIAGNOSTIC INSTRUMENT Safety Inspection Data Sheet.................................... 13-14
14. Troubleshooting
14-1.
Trouble list.................................................................................................................................................. 14-1
14-2.
Messages..................................................................................................................................................... 14-2
14-2-1.
Message ...................................................................................................................................... 14-3
14-2-2.
Assistant Messages ..................................................................................................................... 14-9
15. DISPOSAL the Instrument
15-1.
Precaution of disposal................................................................................................................................. 15-1
15-2.
Disposal of Old Electrical & Electronic Instrument................................................................................... 15-1
16. Probe use and care
16-1.
16-2.
Application use ........................................................................................................................................... 16-1
16-1-1.
Contra indication ........................................................................................................................ 16-1
16-1-2.
Warnings..................................................................................................................................... 16-1
16-1-3.
External Inspection ..................................................................................................................... 16-1
Connecting a Probe to the Instrument ........................................................................................................ 16-2
16-2-1.
Method of connecting an electronic type probe ......................................................................... 16-2
16-3.
About activating of probe ........................................................................................................................... 16-4
16-4.
Usable probe ............................................................................................................................................... 16-5
16-4-1.
16-5.
Use of probe................................................................................................................................ 16-5
16-4-2.
Specifications.............................................................................................................................. 16-7
16-4-3.
Clinical Measurement Accuracy............................................................................................... 16-10
16-4-4.
Clinical Measurement Range.................................................................................................... 16-11
Handling and maintenance of probe......................................................................................................... 16-13
16-5-1.
Caution about handling............................................................................................................. 16-13
16-5-2.
Precautions for performing a puncture operation ..................................................................... 16-14
16-5-3.
Cleaning of probe ..................................................................................................................... 16-15
16-5-4.
Disinfection of probe ................................................................................................................ 16-15
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MN1-5205 Rev.18
16-6.
16-5-5.
Sterilization of probe................................................................................................................ 16-15
16-5-6.
Probe cover............................................................................................................................... 16-15
16-5-7.
Maintenance and Inspection..................................................................................................... 16-15
Transesophageal Echocardiogram probe ................................................................................................. 16-16
16-6-1.
Temperature control System .................................................................................................... 16-16
16-6-2.
Monitoring Surface Temperature............................................................................................. 16-16
17. Acoustic Output Safety Information
17-1.
About acoustic output index ...................................................................................................................... 17-1
17-1-1.
Mechanical index (MI)............................................................................................................... 17-1
17-1-2.
Thermal index (TI)..................................................................................................................... 17-1
17-2.
Ultrasound wave, interaction between vital tissues ................................................................................... 17-3
17-3.
Possible Biological Effects ........................................................................................................................ 17-4
17-4.
17-3-1.
Mechanical effects ..................................................................................................................... 17-4
17-3-2.
Thermal ...................................................................................................................................... 17-5
Derivation and Meaning of MI/TI ............................................................................................................. 17-6
17-4-1.
Introduction ................................................................................................................................ 17-6
17-4-2.
Mechanical index (MI)............................................................................................................... 17-6
17-4-3.
Thermal index (TI)..................................................................................................................... 17-7
17-5.
Setting condition influencing device output .............................................................................................. 17-9
17-6.
Recommendation on ALARA (As Low As Reasonably Achievable)..................................................... 17-10
17-7.
Default Setting ......................................................................................................................................... 17-11
17-8.
Protocol for calculating the measurement uncertainties .......................................................................... 17-12
17-9.
Reference ................................................................................................................................................. 17-21
17-10. Acoustic Output Tables............................................................................................................................ 17-22
17-10-1. Acoustic Output Measurements ............................................................................................... 17-22
17-10-2. Convex Sector Probe................................................................................................................ 17-25
17-10-3. Phased Array Sector Probe..................................................................................................... 17-103
17-10-4. Linear Probe ........................................................................................................................... 17-175
17-10-5. Combination Probe................................................................................................................. 17-247
17-10-6. 3D Probe................................................................................................................................. 17-260
17-10-7. Mechanical Radial Probe ....................................................................................................... 17-278
17-10-8. Mechanical Annular Array Sector Probe .............................................................................. 17-282
17-10-9. Independent Probe.................................................................................................................. 17-284
17-10-10.Ultrasonic Gastrovideo Scope................................................................................................ 17-288
17-10-11.Ultrasonic Bronchofiber videoscope...................................................................................... 17-324
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MN1-5205 Rev.18
1-1.Purpose of Use
1. PRECAUTIONS FOR USE
1-1.
Purpose of Use
This instrument is intended to be used by doctors and other qualified persons for performing slice diagnoses and
blood circulation diagnoses in the following parts of the human body. Do not use it for any other applications.
• Thorax
• Abdomen
• Perineum and pelvis
• Lower limbs
• Back
• Upper limbs
• Head
• Neck
Warning
The acoustic power from this instrument exceeds the upper ophthalmological limit indicated in the U.S. FDA
standards.
DO NOT use this instrument for performing ultrasound diagnosis of the eyes.
Caution
The intended use of probe differs depending upon the type of probe.
Select a probe that meets your purpose of use.
Do not use it for any application that is not covered in the instruction manual of the probe.
The probe can harm the human body.
This section consists of 16 pages.
1-1
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MN1-5205 Rev.18
1-1.Purpose of Use
1-1-1. Precautions concerning acoustic power
The tissues of the human body consist of soft tissues, water, bone, and other tissues. Ultrasound energy is progressively absorbed and attenuated by the body as it penetrates it, hence tissues located behind water, which causes only
a small degree of attenuation, receive a relatively large amount of ultrasound energy.
Also, it is necessary to be careful of bioeffects due to heat in the vicinity of tissues, such as bone, that readily convert
ultrasound energy into heat.
Particularly, a fetus at the bone formation stage is exposed to a high risk of damage due to heating because almost
all of the ultrasound energy passes through the amniotic fluid without being attenuated. Even in the case of a fetus
prior to bone development, the cells are active, hence there is a possibility of growth being affected, even when the
temperature rise is low.
Pro-sound SSD-α10 shows the dynamics of blood flow using the Ultrasound Doppler Method.
Mechanical bioeffects such as heating and cavitation occur when the body is exposed to ultrasound energy for a long
period. You can reduce the risk of damage to the tissues by interrupting the ultrasound energy before it reaches the
level at which tissue damage occurs. To this end, it is necessary to obtain a grasp of the functions of the instrument,
acquire familiarity with the method of operating it, and understand the parameters that affect the acoustic power.
Also, get into the habit of always freezing the image as soon as you have obtained the necessary diagnostic information.
Caution
Minimize acoustic output power setting as low as possible within reason.
Execute ultrasound scanning for only as long as it is necessary for diagnosis. Prolonged use can harm the
human body.
1-1-2. Use with an ultrasound contrast agent
If you wish to use an ultrasound contrast agent, be sure to use only a substance that has been approved for use for
that purpose. See the specific package insert for the contrast agent being used for details.
Caution
Watch to make sure that the patient is not abnormally affected during the exams using the ultrasound contrast
agent.
Cardiac rhythm disturbances during perfusion studies using gas ultrasound contrast agents have been
observed in the diagnostic range of Mechanical Index (MI) values. See the specific package insert for the
contrast agent being used for details.
1-1-3. Use with a general pharmaceutical
If you perform an ultrasound examination after having the patient ingest a general pharmaceutical, the ultrasound
may affect the pharmacological effect of the pharmaceutical.
Before using a general pharmaceutical, carefully read the instructions for using the pharmaceutical and also any cautionary notes.
1-2
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MN1-5205 Rev.18
1-1.Purpose of Use
1-1-4. Use with Other Medical Devices
Combined use with High frequency surgical equipment
When the device is used concomitantly with a high frequency surgical equipment,the device and the parts there of
have not been equipped with any means to protect the patient from burn injury.
The high frequency surgical equipment may apply an electromagnetic field and electric current of high frequency to
the patient intentionally.
With these radiated high frequencies, the device may be affected with interference when it is drawing monochrome
or color images.
Caution
(1) When a probe, examining operator's hands, and a puncture attachment are located on the path of high frequency electrical current, there may be incidents of the damage to the probe and the burn injuries of the
patient or the examining operator.
(2) As damage to an insulating membrane and burn injuries to the patient and examining operator may be
caused by rough handling of the electrode needle, do not put an excessive force to the needle in puncture
with using a puncture attachment guiding it properly.
(3) Operate the device with caution paying attention to the positions of the counter electrode plates and the
connecting cord against the probe.
Use in conjunction with a cardiac defivrillator
Caution
Do not use in conjunction with a cardiac defivrillator.
1-3
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MN1-5205 Rev.18
1-2.Classification
1-2.
Classification
1-2-1. According to the type of protection against electric shock:
• Class I instrument
1-2-2. According to the degree of protection against electric shock:
• Type BF instrument
Classification
Probe
Physiological signal
Type BF instrument
All probes
ECG lead, PULSE transducer, PCG microphone
Table Classification according to degree of protection
[Remark]
Type BF instrument refers to a component of the ultrasound diagnostic instrument, which is consisting of the ultrasound probe and ECG lead only and not used directly for a heart but applied indirectly from outside.
1-2-3. According to the degree of protection against harmful ingress of water
• Ordinary instrument(IPX0)
Warning
The instrument is not protected in any way against water ingress, so do not use it in a place where there is a
possibility of water getting into it.
Take care not to spill liquid onto or into the instrument. This is because of the danger of electric shock. If you
do happen to spill liquid on the instrument, contact one of Aloka's sales offices or agents listed on the back
cover of this instruction manual.
1-2-4. According to the degree of safety of application in the presence of a flammable
anaesthetic mixture with air or with oxygen or nitrous oxide
• Instrument is not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or
nitrous oxide.
Danger
Do not use this instrument in a flammable atmosphere.
It may cause an explosion if used in such an atmosphere.
1-2-5. According to the mode of operation
• Continuous operation
1-4
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MN1-5205 Rev.18
1-3.Safety
1-3.
Safety
Warning
Do not disassemble or remodel this instrument.
Unexpected accident can take place.
Warning
Clean and disinfect a probe every time it is used.
Using contaminated probes may result in infection.
Warning
Wear medical gloves during inspection, and wash your hands after inspection; otherwise you may become
infected from patients.
Caution
Use of an ultrasonic beam into the air without coating the probe with an ultrasound medium, may cause surface temperature to rise.
Before using, coat probe adequately with ultrasound gel.(*)
When probe is not in use even during an examination, freeze image.
In the event that the surface temperature feels abnormal, immediately stop using the probe, and contact our
office.
(*) When performing a puncture or a surgical operation, use ultrasound medium as described in the instruction manual for the probe.
Caution
Hold a probe tightly not to slip, especially when using ultrasound gel or others; otherwise, the probe may slip
out of your hands and hit a patient.
Avoid rapid temperature change which may cause condensation.
Avoid using where condensation exist.
Caution
Always use this in dried state. Condensation may appear when using from cold to warm places.
Use without proper care, then, can cause short-circuiting.
1-5
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MN1-5205 Rev.18
1-4.Environmental Conditions
1-4.
Environmental Conditions
1-4-1. Working environment
This instrument is intended to be used under the following environmental conditions. Be sure to install it in an environment that satisfies these conditions.
1-4-1-1.
Working environment
Ambient temperature:
10 — 40°C
Relative humidity:
30 — 75%
Atmospheric pressure:
700 — 1060 hPa
Caution
The presence of electromagnetic waves may result in a mis-diagnosis or a breakdown of the instrument. If the
instrument is to be used near a motor (elevator, pump room, etc.), power transmission line or wireless instrument, it is necessary to electrostatically shield it.
1-4-2. Storage environment and moving / transport environment
Store, move or transport the equipment in an environment that satisfies the following conditions.
1-4-2-1.
Storage environment and moving / transport environment
Ambient temperature:
−10 — 50°C
Relative humidity:
10 — 90%
Atmospheric pressure:
700 — 1060 hPa
Avoid rapid temperature change which may cause condensation.
Avoid using where condensation exist.
Caution
Always use this in dried state. Condensation may appear when moving from cold to warm places.
Use without proper care, then, can cause short-circuiting.
1-6
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MN1-5205 Rev.18
1-5.Power Requirements
1-5.
Power Requirements
The power requirements for this instrument are as follows.
Power requirements
Unit
Rated supply voltages or voltage ranges
(100 — 120 V specifications)
100 — 120V
(200 — 240 V specifications)
200 — 240V
Rated frequency or rated frequency range
50/60Hz
Power input
1200VA
Auxiliary mains socket outlets
350VA
Table Power requirements
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MN1-5205 Rev.18
1-6.Electromagnetic compatibility
1-6.
Electromagnetic compatibility
1-6-1. The prevention of electromagnetic wave disorders
This device meets IEC60601-1-2:2001, Amendment 1 which is the international standard for EMC with medical instrument.
Medical devices are apt to emit electromagnetic waves or receive interference from electromagnetic waves.
The EMC standard prescribes the testing of electromagnetic wave interference in transmitting and receiving.
An electromagnetic wave transmit testing relates to electromagnetic wave interferences being transmitted from
devices that are tested.
The electromagnetic wave level that occurs from a device is called as "electromagnetic emission" and the tolerance
of a device for the electromagnetic wave interference from other device is called as "electromagnetic immunity.
Caution
(1) Install this instrument where the electromagnetic radiation does not affect.
Note that the electromagnetic radiation may cause the following phenomena on this instrument.
• Distortion in viewing monitor
• Noise on physiological signals
• Noise from loudspeaker
• Noise on image
(2) Position this instrument and its cables (e.g. probe cables, ECG cables, I/O cables, etc.) as far away as
possible from other medical electrical instrument.
(3) Note that electromagnetic radiation from this instrument may cause the abnormal operation on the other
medical electrical instrument nearby. In this case, stop using such instrument immediately.
(4) This instrument intended to use in hospitals and/or institutions in order to prevent the electromagnetic
interference.
Use this instrument in facilities equivalent to the hospital or institution.
Note that electromagnetic radiation from this instrument may cause the disturbance to the radio receiver,
TV set, etc.
Position this instrument as far away as possible from the radio receiver, TV set, and its cables and
antenna.
(5) Do not use the portable radio communication devices (e.g. cellular phone, cordless phone, radio transceiver, etc.) near this instrument.
(6) If the AC line voltage to this instrument fluctuates, the instrument may lock-up.
Shut off the instrument.
Keep power switch off for 5 minutes. Then the instrument automatically shut itself off.
After that, reboot the power.
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MN1-5205 Rev.18
1-6.Electromagnetic compatibility
1-6-2. The guideline of electromagnetic compatibility
Our ultrasound diagnostic devices have been confirmed that no electromagnetic waves against the electromagnetic
wave interference standard are emitted by testing. As an ultrasound diagnostic device receives radio frequency signals (supersonic wave signals on a Radio Frequency), there is a possibility to receive the electromagnetic wave interference that occurs from electromagnetic wave sources.
As for the electromagnetic sources having possibility to generate electromagnetic wave disorders, there are medical
instrument, communication devices, and radio or television broadcasting antennas.
When cellular/mobile communication machinery such as cellular phones, transceivers, and amateur radio instrument
are used, there can be effects affecting the operations of this device.
The device should be placed apart from other electrical apparatuses (including medical use) as much as possible.
When other electric apparatuses are installed in the neighborhood of this device, confirm the following.
• Are there any adverse effects of the electromagnetic waves occurring from other instrument affecting to this
device ?
• Are there any adverse effects of the electromagnetic waves occurring from this device affecting to other
instrument ?
1-6-3. Guidance and declaration directive concerning electromagnetic emission
SSD-α10 is intended to use in the electromagnetic environment which is specified in the following.
It is desirable for customers or users of SSD- α10 to confirm that the SSD- α10 is used in such a environment.
Emission testing
Conformity
Electromagnetic environment Guidance
CISPR11
RF emission
Group1
The SSD-α10 uses RF energy only
for its internal functions.
Therefore, the RF emission is very
low and there is few possibility of
allowing interferences to other
electronic instrument in the
neighborhood.
CISPR11
RF emission
Class B
IEC 61000-3-2
Higher harmonic emission
Class A
IEC 61000-3-3
Power-supply variations/flickers emission
Conformity
The SSD-α10 is suitable for using
in all buildings including general
residential housing and connecting
to the commercial under-voltage
power supply system directly which
is supplied to housing as home-use.
Table Guidance and declaration directive concerning electromagnetic emission
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MN1-5205 Rev.18
1-6.Electromagnetic compatibility
1-6-4. Restrictions for use
It is necessary for a doctor to examine whether any artifacts affect images or diagnoses with effect attributable to the
electromagnetic wave interference.
1-6-5. Essential performance
The ultrasound diagnostic devices has confirmed not to afferct the essential performance (its absence or degadation
would result in an unacceptable risk) or safety of the system in the testing of the electromagnetic immunity based
on IEC60601-1-2:2001, Amendment 1.
Essential
performance
contents
reference
SCAN AREA
Scanning range of B mode image
SCAN AREA switch
(How to Use)
Marker
Scale marks (distance, time and flow velocity) display
9. SCREEN DISPLAY
Velocity Range
Display range (scale mark) of flow velocity in the
Doppler image display
VEL RANGE switch
(How to Use)
M, D cursor
Detect the M mode and the baseline of the Doppler
pattern of the Bmode image
CURSOR switch
(How to Use)
Flow Area
Display in color on the Flow mode image
9. SCREEN DISPLAY
Image /
Frequency
Switch the transmitting/receiving frequencies of the probe
of the B, D, M, Flow, THE, ExPHD(THE), CHE or
ExPHD(CHE) mode
Image Freq menu
(How to Use)
Focus
Number of the focal point and each focal point position
FOCUS switch
(How to Use)
Acoustic Power
Control the acoustic power
17.Acoustic Output Safety
Information,
ACOUSTIC POWER switch
(How to Use)
Frame Rate
Combination of Line Density for black & white and color
images, in the Flow or the Power Flow mode.
Frame Rate menu
(How to Use)
Sample Volume
Volume of the sample gate that extracts the signals from
the B mode image in the PW Doppler mode
Sample Volume menu
(How to Use)
Image Select (D)
Image quality setting of Doppler spectrum image
Image Select (D) menu
(How to Use)
Average(Flow)
Number of transmissions used to display blood flow
Average (Flow) menu
Preset : Flow, Power Flow, eFlow,
Tissue Flow, Tissue Power Flow
(How to Use)
Image Select
(Flow)
Image quality setting of color image on the Flow mode
and Power Flow mode
Image Select (Flow) menu
(How to Use)
1-10
Page 19
MN1-5205 Rev.18
1-6.Electromagnetic compatibility
Essential
performance
contents
reference
Puncture
Display Puncture Guideline
Pucture menu
Preset : Graphics
(How to Use)
Message
Warning messages indicating the correct method of
operation, and an alarm tone.
14. TROUBLESHOOTING
Angle Correction
Correct the flow velocity value corresponding to the angle
of incidence of the Doppler beam
Angle Correct menu,
Preset : Doppler1, 2,
Tissue Doppler
(How to Use)
Heart Rate
Display
Compute and display the heart rate from detected R-wave
(HR***)
Display of physiological signals,
Physio menu,
Preset : Physio
(How to Use)
R-Wave Blink
Mark
Display R-wave mark when R-wave is detected
Physiological signals,
Preset : Physio
(How to Use)
1-11
Page 20
MN1-5205 Rev.18
1-6.Electromagnetic compatibility
1-6-6. Guidance and Declaration directive concerning electromagnetic immunity
SSD- α10 is intended to use in the electromagnetic environment which is specified in the following.
It is desirable for customer or users of SSD- α10 to confirm that the SSD- α10 is used in such environments.
Immunity
examination
IEC 60601Testing
level
Conformity level
IEC 61000-42Electrostatic
discharge (ESD)
± 6kV contact
± 8kV atomospheric
± 6kV contact
± 8kV atomospheric
It is desirable that the floor
material is made of wood,
concrete or ceramic tile.
If the floor is covered with
synthetic materials, it is desirable
that the relative humidity of these
is 30% at least.
IEC 61000-4-4
Electrical fast
transient / burst
For Power supply line
± 2kV
For Input line ± 1kV
For Power supply line
± 2kV
For Input line ± 1kV
It is desirable that the quality of
electric power source is the same
as the standard business or
hospital environments.
IEC 61000-4-5
Surge
± 1kV
line(s) to line(s)
± 2kV
line(s) to earth
± 1kV
line(s) to line(s)
± 2kV
line(s) to earth
It is desirable that the quality of
electric power source is the same
as the standard business or
hospital environments.
IEC 61000-4-11
Voltage dip,
Short-time power
cut, and voltage
fluctuation on the
power supply input
line
< 5% UT
(>95% Fall in UT)
0.5 cycle interval
< 5% UT
(>95% Fall in UT)
0.5 cycle interval
< 40% UT
(>60% Fall in UT)
5 cycle interval
< 40% UT
(>60% Fall in UT)
5 cycle interval
< 70% UT
(>30% Fall in UT)
25 cycle interval
< 70% UT
(>30% Fall in UT)
25 cycle interval
It is desirable that the quality of
electric power source is the same
as the standard business or
hospital environments.
When the user of SSD-α10
demands continuous operations
even during the time of power cut,
it is recommendable that the
SSD-α10 is supplied of power
either with an
uninterruptive power supply
or a battery.
< 5% UT
(>95% Fall in UT)
5 seconds
< 5% UT
(>95% Fall in UT)
5 seconds
3 A/m
3 A/m
IEC 61000-4-8
Power frequency
(50/60Hz) magnetic
field
Remarks
Electromagnetic environment
- Guidance
It is desirable that the power
frequency magnetic field has
the same level of characteristic as
the general place such as the
standard business or hospital
environments.
UT is AC power supply voltage before applying a testing level.
Table Guidance and Declaration directive concerning electromagnetic immunity
1-12
Page 21
MN1-5205 Rev.18
1-6.Electromagnetic compatibility
1-6-7. Guidance and Declaration directive concerning electromagnetic immunity
(conduction RF and emission RF).
SSD-α10 is intended to use in the electromagnetic environment which is specified in the following.
It is desirable for customers or users of SSD-α10 to confirm that the SSD-α10 is used in such an environment.
Immunity
examination
IEC 60601Testing
level
Conformity
level
Electromagnetic environment
- Guidance
Cellular and Mobile RF communication
instrument including cables shall not be used
close to the any parts of this SSD-α10 within
the recommended separation distances
calculated by the equations corresponding to
the frequencies of those transmitters
IEC 61000-4-6
Conduction RF
IEC 61000-4-3
Emission RF
3 Vrms
150 kHz —80MHz
3 V/m
80MHz—2.5GHz
V1=3V
Recommended separation distances
E1=3 V/m
Here, P stands for the maximum output power
rating that expresses in watt (W) of the
transmitter by the transmitter manufacturing
company, and d is the recommended
separation distance expressed in meter (m).
The electric field strength from a
non-transitory RF transmitter shall be set at
lower than the conformity level in each
frequency bandwidth b as having been decided
by the spot electromagnetic investigation a.
As for the next symbol, it is displayed on the
device which generates
electromagnetic waves intentionally.
In the neighborhood of the device displaying
this symbol, interference may occur.
Table Guidance and Declaration directive concerning electromagnetic immunity
1-13
Page 22
MN1-5205 Rev.18
1-6.Electromagnetic compatibility
Remark1 Apply high frequency ranges in 80MHz and 800MHz.
Remark2 These guidances are not applicable in all circumstances.
As for the electromagnetic diffusion, it is influenced by reflection or absorption of buildings, substance, and
humans.
a
For example, it is not possible theoretically to estimate precisely field intensities from fixed transmitters of
wireless-telephone-base stations, such as Mobile radio, amateur radio, AM/FM radio and TV broadcast base
stations.
Consider a spot electromagnetic investigation to assess electromagnetic environment caused by a
non-transitory RF transmitter accurately.
When the field intensity measured at the place where SSD-α10 is used is higher than the applied RF
conformity level mentioned above, it shall be monitored whether the SSD-α10 operates normally.
When abnormal movement was confirmed, an investigation for the placement or installment of the SSD-α10
may be necessary.
b For the outside of 150kHz —80MHz frequency bandwidth, it is desirable that the field intensity is less than
3V/m.
Table Guidance and Declaration directive concerning electromagnetic immunity
Recommended separation distance between cellular and mobile RF communication instrument and SSD-ALPHA10.
SSD-ALPHA10 is intended to use in the electromagnetic environment that RF interference is controlled.
Customers or users of SSD-ALPHA10 can promote the prevention of EMI (Electromagnetic interference) by
managing the shortest distance between mobile RF communication instrument (a transmitter) and SSDALPHA10 in the following recommendation based on the maximum output of transmitter devices
The maximum
output power rating
of a transmitter (W)
The separation distances (m) based on the frequencies of transmitters
150kHz—80MHz
80MHz—800MHz
800MHz—2.5GHz
0.01
0.116
0.116
0.233
0.1
0.369
0.369
0.738
1
1.167
1.167
2.333
10
3.689
3.689
7.378
100
11.67
11.67
23.33
For a rated transmitter with its maximum output electricity not listed above, the recommended distance of d
expressed in meter (m) can be decided by the equation corresponding to the frequency of the transmitter. The P in
the equation is the rating of the maximum output electricity of a transmitter expressed in watt (W) by the
transmitter manufacturing supplier.
Remark1 Apply a high frequency band in separation distance for 80MHz and 800MHz.
Remark2 These guidelines are not applicable for all situations. As for the electromagnetic diffusion, it is
influenced by reflection or absorption of buildings, substance, and humans.
Table Recommended separation distance between cellular and mobile RF communication instrument and SSD-α10.
1-14
Page 23
MN1-5205 Rev.18
1-7.Safety Instructions for Connecting Network Devices
1-7.
Safety Instructions for Connecting Network Devices
1-7-1. Electrical safety Instructions for Connecting Network Devices
The electromagnetic compatibility (EMC) of this device is in conformity with the IEC60601-1-2:2001, Amendment
1 which is the international standard for EMC with medical instrument.
The following instructions are applicable, when connecting network devices to the Ultrasound system.
The instructions are provided in order for the entire system with network devices to meet
IEC60601-1-1 Electrical Safety Standard.
1-7-1-1.
Network Devices
All non-medical network devices connected to the Ultrasound system, including Hubs, Work Stations and Personal
Computers, must comply with IEC60950-1 standard and must be Class I device.
Furthermore all configurations shall comply with the requirements for medical electrical systems (see IEC 606011-1 or clause 16 of theIEC 60601-1:2005, respectively).
There is the possibility that local law and regulatory requirements take priority over the above mentioned requirements.
If in doubt, consult your local representative or the technical service department.
1-7-1-2.
Installation and Network Connections
(1)
Non-medical devices must be kept at least 1.5 meters away from a patient.
(2)
When connecting the Ultrasound system with Computer Devices located out side of the Ultrasound examination room, a separation device (Network Hub) must be used in-between.
Connecting connectors
LAN cable connector
Cable name
LAN cable: Straight (in case of hub-use),
cross (when connecting to PC directly)
Maximum cable length
20m
Caution
When a cable other than the specified or longer than the maximum length is used, the EMC characteristic of
this device may be influenced.
1-8.
Other precautions
• Once you switch ON the ultrasound diagnostic equipment, do not switch it OFF again for 2 - 3 minutes. If you
switch OFF the equipment while it is starting up, the hard disk may break down.
• A primary battery is used to maintain the unit in an operable condition. If the battery runs down, the clock on the
system is shown a wrong time. (In this case, the operation of the ultrasound diagnostic equipment is unaffected.)
If the above phenomenon occurs, the battery must be replaced, so contact your nearest Aloka branch to do this.
The equipment contains a primary battery (lithium battery), so when disposing of it conform to the “Laws Relating
to the Disposal and Cleaning of Waste”.
1-15
Page 24
MN1-5205 Rev.18
1-7.Safety Instructions for Connecting Network Devices
1-16
Page 25
MN1-5205 Rev.18
2-1.Symbols and Indications
2. MEANING OF SYMBOLS, INDICATIONS
AND TERMS
2-1.
Symbols and Indications
2-1-1. Safety alert symbols
The four indications [Danger], [Warning], [Caution] and [Note] used on this instrument and in this instruction manual have the following meaning.
Danger
Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.
A warning message is inserted here.
Warning
Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
A warning message is inserted here.
Caution
Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury.
A caution message is inserted here.
Note
Indicates a strong request concerning an item that must be observed in order to prevent damage or deterioration of the instrument and also to ensure that it is used efficiently.
An explanatory text is inserted here.
This section consists of 6 pages.
2-1